GORE EXCLUDER AAA Endoprosthesis PLC141200Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00733132618675), received between Dec 4, 2018 and Jun 9, 2026 — classified as 1 death, 24 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. ADDITIONALLY, ENDOSTAPLES /ENDOANCHORS WERE PLACED DURING THE INDEX PROCEDURE. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 58 MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY (RCIA) MEASURED 15.4 MM AND LEFT COMMON ILIAC ARTERY (LCIA) MEASURED 12.5MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME (SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT FOLLOW-UP CTA WHICH THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 58MM. NO ENDOLEAKS OR OTHER DEVICE INTEGRITY EVENTS WERE REPORTED. ON (B)(6) 2026, THE PATIENT UNDERWENT FOLLOW-UP CTA WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 58MM. NO ENDOLEAKS OR

  Patient problems: Vascular Dissection

  MAUDE report 25446734 ↗
• MalfunctionApr 3, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT OF A INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6), 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 50MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME (SELF-CARE) ON (B)(6), 2026. ON (B)(6), 2026, REVIEW OF FOLLOW-UP IMAGING BY GORE IMAGING SCIENCES (GIS) REPORTS THERE APPEARS TO BE COMPRESSION OF THE CONTRALATERAL LEG ON THE LEFT SIDE, LIKELY DUE TO LIMB COMPETITION. THIS AREA MEASURES ~ 14 MM ON THE PRE-IMPLANT CTA. ADDITIONALLY, THERE APPEARS TO BE A LACK OF WALL APPOSITION AT THE PROXIMAL END OF THE TRUNK. THE SITE/CSD DOES NOT PROVIDE RECORD OF THE FOLLOW-UP IMAGING TO DATE. THERE ARE NO INDICATED REINTERVENTIONS SCHEDULED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780341 ↗
• InjuryDec 18, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN INNER BRANCH ENDOVASCULAR AORTIC PROCEDURE TO TREAT AN AORTO-ILIAC ANEURYSM. THERE WERE MULTIPLE GORE DEVICES IMPLANTED, SUCH AS A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT) DEVICE, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (CEB) DEVICE IN THE RIGHT ILIAC BIFURCATION, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (HGB) DEVICE IN THE RIGHT INTERNAL ILIAC ARTERY, A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC) IN THE LEFT COMMON ILIAC ARTERY. ON (B)(6) 2025, MULTIPLE THROMBI WERE IDENTIFIED WITHIN THE IMPLANTED DEVICES. THE ETIOLOGY OF EACH THROMBUS FORMATION REMAINS UNDETERMINED. IT WAS ADDITIONALLY STATED BY PHYSICIAN THAT THE CXT DEVICE IS NOT PLANNED TO PERFORM RELINING. THE PATIENT IS PRESENTLY ASYMPTOMATIC. ON (B)(6) 2026, THE CEB, HGB, AND A PLC DEVICE HAD RELINING FOR EACH OF THE DEVICES, AND WAS COMPLETED WITHOUT PROBLEMS. AS REPORTED, THE RELINING WAS SUCCESSFULLY PERFORMED AND ALL 3 DEVICES (CEB, HGB, PLC) REMAINED IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 23836331 ↗
• InjuryDec 16, 2025Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL ANEURYSM IV USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. ALSO, WERE IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, A GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED, THE PATIENT HAD A SPINAL CORD ISCHEMIA WITH FLACCID PARALYSIS OF THE LOWER EXTREMITY. THE PATIENT HAD MINOR MOTOR DEFICIT, ABLE TO WALK WITH ASSISTANCE OR INDEPENDENTLY (IMPLIES THE ABILITY TO MOVE AGAINST GRAVITY). REPORTEDLY, NO DEVICE OR VESSEL OCCLUSION WAS NOTICED. ON (B)(6) 2025, THE PATIENT HAD A RECUSE MANEUVERS TREATMENT- LUMBAR DRAINAGE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE SPINAL CORD ISCHEMIA WAS A DISTAL THORACIC AORTIC STENT AS PART OF THE PROCEDURE. THE CAUSE OF PARALYSIS OF THE LOWER EXTREMITY AND THE PATIENT MINOR MOTOR DEFICIT WAS LIKELY THE TEVAR PROCEDURE. ON (B)(6) 2025, THE PATIENT DISCHARGED HOME. THE PATIENT WAS DIAGNOSED TO HAVE GI BLEED AND PANCREATIC MASS BUT DECLINED TO BE FURTHER EVALUATED.

  Patient problems: Ischemia; Movement Disorder; Paralysis

  MAUDE report 23820699 ↗
• InjuryDec 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILZING TAMBE THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED ON THE SAME DAY, UPON WAKING FROM THE SURGERY, PATIENT'S LEGS WERE PARALYZED. A RESCUE SPINAL DRAIN WAS PLACED RIGHT AFTER THE PROCEDURE UPON THE PATIENT WAKING UP. IT WAS ALSO REPORTED PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS PARALYSIS, AS THERE WERE NO ISSUES DURING THE PROCEDURE. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 23790722 ↗
• InjuryNov 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A RUPTURED ANEURYSM USING A GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS TRUNK (CXT) AND 2 GORE®EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEGS. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING AN EXPLANT DUE TO AN AORTOENTERIC FISTULA. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Fistula

  MAUDE report 23522986 ↗
• DeathAug 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. AN ATAA43720160A TAMBE AORTIC COMPONENT, CEB231410A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT, AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENTS (PLC141000 AND PLC141200) WERE IMPLANTED. A CSF DRAIN AND INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING (MEP/SSEP) WERE UTILIZED PROPHYLACTICALLY DURING THE PROCEDURE. ON THE SAME DAY, CHOLESTEROL EMBOLI SYNDROME, ACUTE KIDNEY INJURY (AKI), AND RIGHT LOWER EXTREMITY ISCHEMIA WERE REPORTED. THE CHOLESTEROL EMBOLI SYNDROME WAS NOTED AS DISEASE RELATED. THE AKI WAS NOTED AS NOT RELATED TO THE DEVICE, PROCEDURE, OR DISEASE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR RIGHT COMMON FEMORAL ARTERY THROMBOENDARTERECTOMY, RIGHT FEMORAL ARTERY INTERPOSITION GRAFT PLACEMENT, AND THROMBECTOMY OF THE RIGHT FEMOROPOPLITEAL ARTERY. THE ISCHEMIA WAS NOTED AS RESOLVED ON THE SAME DAY. ON (B)(6) 2025, THE PATIENT ENTERED RESPIRATORY FA

  Patient problems: Embolism/Embolus; Ischemia; Renal Impairment; Respiratory Failure

  MAUDE report 22926036 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2024, THERE WAS A REINTERVENTION TO TREAT ANEURYSM ENLARGEMENT FOR AN UNDETERMINED ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN EXPLANTED ALL DEVICES DUE TO AN INFLAMMATORY ANEURYSM (POSSIBLY INFECTED BUT CULTURES CAME BACK NEGATIVE) AND FOR A PROXIMAL TYPE I ENDOLEAK. ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). THE PHYSICIAN PERFORMED AN OPEN CONVERSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 22637873 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BACK AND CHEST PAIN. IMAGES REVEALED INFECTED GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE PHYSICIAN EXPLANTED ALL THREE IMPLANTED DEVICES. AN OPEN REPAIR WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, WHEN THE PATIENT WAS IMPLANTED, THERE WAS NO INFECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22140608 ↗
• InjuryMay 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE, UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC141200 SN # (B)(6) AND PLC141200 SN # (B)(6) AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT281412 SN # (B)(6) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, A GRAFT INFECTION WAS OBSERVED.. IT WAS ALSO REPORTED PATIENT HAS NO KNOWN HISTORY OF PREVIOUS INFECTIONS, AND IT IS UNKNOWN WHAT CAUSED THE INFECTION. IT ALSO UNKNOWN WHICH DEVICE HAS AN INFECTION. PATIENT WAS PUT ON ANTIBIOTICS AND IS AWAITING EXPLANT SURGERY. IT WAS LATER REPORTED PATIENT UNDERWENT EXPLANT SURGERY ON (B)(6) 2025, IN WHICH ALL DEVICES WERE EXPLANTED. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 21961937 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE TO TREAT A DISSECTION IN THE LEFT DISTAL COMMON ILIAC ARTERY UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS, TWO GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN® DEVICE) AND THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT). REPORTEDLY, PATIENT HAD A TORTUOUS AORTIC NECK AND DURING INITIAL WIRE ACCESS THERE WAS A DISSECTION NOTED IN THE VISCERAL SEGMENT, THIS WAS RESOLVED AND COVERED WITH THE CONFORMABLE MAIN BODY GRAFT. THE PROCEDURE WENT WELL WITH ALL DEVICES IMPLANTED. THE VIABAHN AND VBX WERE IN THE PATIENT'S LEFT EXTERNAL ILIAC ARTERY AND EXTENDED UP INTO THE CONTRALATERAL LEG THEN ANOTHER TWO VBXS AND A VIABAHN WERE IN THE LEFT INTERNAL EXTENDING UP INTO THE SAME CONTRALATERAL LEG TO CREATE PARALLEL STENTS. AT THE END OF THE PROCEDURE, IT WAS UNCERTAIN BUT THERE WAS A POSSIBLE TYPE 3 ENDOLEAK FROM THE PARALLEL VBX STENTS THAT WERE INSERTED IN THE HYPOGASTRIC AND EXTERNAL ILIAC ARTERIES ON THE PATIENT'S LEFT SIDE. PHYSICIAN DECIDED TO WAIT AND SEE IF THE ENDOLEAK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913638 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THE PATIENT HAD A ¿SHORT¿ AORTIC NECK. IT WAS REPORTED THAT ALL DEVICES WERE IMPLANTED BUT THERE WAS NOT A GOOD SEAL AT THE PROXIMAL AORTIC NECK, DUE TO AORTIC NECK ANATOMY. THE PHYSICIAN CHOSE TO EXPLANT THE IMPLANTED DEVICES AND CONVERTED TO AN OPEN REPAIR. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21767831 ↗
• InjuryJan 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON DECEMBER 12, 2024, THE PHYSICIAN BECAME AWARE OF A TYPE 2 ENDOLEAK AS PATIENT HAS A LEFT ACCESSORY RENAL FEEDING THE BIG LEFT KIDNEY TUMOR. ON DECEMBER 13, 2024, THE FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN OF THIS EVENT AND REVIEWED IMAGES WHICH SHOWED THE PROXIMAL GRAFT IS NOT WELL APPOSED NOR THE RIGHT COMMON ILIAC ARTERY LIMB AS PHYSICIAN WAS CONCERNED ON THE NECK ENLARGEMENT (ANEURYSM SIZE UNKNOWN). PATIENT HAS TYPE 1A ENDOLEAK ON THE TRUNK IPSILATERAL LEG CONFORMABLE AND TYPE 1B ENDOLEAK ON THE CONTRALATERAL LEG. THE PHYSICIAN PLANS ON WORKING WITH A UROLOGIST TO DO A NEPHRECTOMY FOR THE TUMOR AND LIGATE THE SOURCE OF THE TYPE 2 ENDOLEAK AND WILL REFER PATIENT FOR THE TYPE 1A AND 1B TO THE VASCULAR SURGEON IN LAS VEGAS FOR FOLLOW UP TREATMENT.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21125073 ↗
• InjuryOct 15, 2024Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR A LARGE ANEURYSM AROUND THE ILIAC ARTERY USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THIS PROCEDURE, THE RIGHT INTERNAL ILIAC WAS COILED. ON (B)(6) 2024, A REINTERVENTION OCCURRED BECAUSE THE LIMB PULLED OUT OF THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN EXTENDED DISTALLY WITH ANOTHER EXCLUDER AND A VBX DEVICE.

  Patient problems: Clinical Endoleak

  MAUDE report 20451130 ↗
• InjuryJun 18, 2024Device Stenosis; Device Stenosis

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE-9 INFRARENAL ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENTS-PLC141200 ON THE LEFT AND PLC121400 ON THE RIGHT). ON (B)(6) 2024 DURING A FOLLOW-UP IMAGING, PLC141200 DEVICE APPEARED TO BE THROMBOSED. PHYSICIAN ALSO REPORTED THE LIMB WAS CRUSHED. IT WAS ALSO REPORTED THAT THE PHYSICIAN MENTIONED THERE WAS STENOSIS AT THE EDGE OF THE PLC121400 DEVICE (IMPLANTED ON THE RIGHT SIDE), AND THE DEVICE REMAINED PATENT. ON (B)(6) 2024. PATIENT UNDERWENT A REINTERVENTION SURGERY. PHYSICIAN PERFORMED A FEM BYPASS TO TREAT THE THROMBOSIS AND TREATED THE STENOSIS BY EXTENDING THE RIGHT SIDE WITH ANOTHER LIMB. PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF REPORTED THROMBOSIS AND COMPRESSION IS UNKNOWN. FSA WAS NOT AT THE PROCEDURE. AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19563640 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (MODALITY AND DATE IS UNKNOWN), REVEALED ¿SUSPECTED BILATERAL ILIAC ARTERY STENOSIS/GRAFT COMPRESSION INSIDE TREATED AREA¿. AN ANGIOGRAM AND EVALUATION FOR TREATMENT OF POSSIBLE BILATERAL ILIAC STENOSIS/GRAFT COMPRESSION WILL OCCUR ON JANUARY 04, 2024, WITH MAGGIE LIN, MD. EVENT IS ONGOING AT THIS TIME.

  Patient problems: Vasoconstriction

  MAUDE report 18528240 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE, AND TWO CONTRALATERAL LEGS). REPORTEDLY, THE NECK OF THE AORTA BECAME ANEURYSMAL (ANEURYSM GROWING BUT SIZE UNKNOWN) WITH A CLEAR TYPE 1A ENDOLEAK ON THE STENT GRAFT TRUNK IPSILATERAL LEG CONFORMABLE THAT WAS SEEN ON ANGIO (DATE UNKNOWN) DUE TO DISEASE PROGRESSION. ON (B)(6) 2023, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE GORE DEVICES AND PHYSICIAN DID AN OPEN SURGICAL REPAIR. PATIENT IS DOING OKAY.

  Patient problems: Aneurysm expansion

  MAUDE report 17861951 ↗
• MalfunctionMay 8, 2023Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CONTRALATERAL LEG COMPONENT (PLC141200/ (B)(6)) WAS USED TO EXTEND THE IPSILATERAL SIDE OF THE (B)(6) DEVICE AT THE LEFT COMMON ILIAC ARTERY.

  Patient problems: Aneurysm

  MAUDE report 16891263 ↗
• InjuryFeb 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE REINTERVENTION WAS SUCCESSFUL, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16354048 ↗
• InjuryApr 12, 2022Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AORTIC ANEURYSM AND WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON (B)(6) 2022. DURING THE PROCEDURE, THE LEFT HYPOGASTRIC ARTERY WAS COVERED DUE TO PATIENT ANATOMY. IT WAS CONFIRMED THAT THE CORRECT LENGTH OF THE PLANNED CONTRALATERAL LEG ENDOPROSTHESIS WAS USED. THE PATIENT TOLERATED THE PROCEDURE. NO FOLLOW UP PROCEDURE IS SCHEDULED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14086331 ↗
• InjuryMar 21, 2022Migration; Migration

  ON (B)(6) 2019 THE PATIENT WAS IMPLANTED WITH THE FOLLOWING GORE® EXCLUDER® AAA ENDOPROSTHESES FOR ENDOVASCULAR ANEURYSM REPAIR/TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. RLT231414 (GORE LOT/SN: (B)(4)) PLC141200 (GORE LOT/SN: (B)(4)) AS REPORTED BY THE PHYSICIAN FOR HISTORY OF THE PRESENTED ILLNESS, THE POST-PROCEDURE ULTRASOUND SURVEILLANCE SUGGESTED CONTINUED RESIDUAL ANEURYSM SAC EXPANSION AND CT ANGIOGRAPHY SUGGESTED AN ENDOLEAK WAS PRESENT. ATTEMPTED ENDOLEAK REPAIR BY INTERVENTIONAL RADIOLOGY CONDUCTED IN (B)(6) 2022 SUGGESTED A TYPE I OR TYPE III ENDOLEAK. THE ANEURYSM SAC REMAINED ASYMPTOMATIC. ON MARCH 17TH, 2022 THE TYPE III ENDOLEAK WAS CONFIRMED BETWEEN THE OVERLAP OF THE GORE® EXCLUDER® AAA TRUNK IPSILATERAL C3 AND CONTRALATERAL LEG ENDOPROSTHESES . AS REPORTED, IT IS UNKNOWN IF THE CAUSE OF THE ENDOLEAK IS DUE TO INCORRECT PLACEMENT OF THE CONTRALATERAL LIMB RESULTING IN INSUFFICIENT OVERLAP, OR DUE TO ENDOPROSTHESIS MIGRATION. ON MARCH 17TH, 2022 REINTERVENTION WAS CONDUCTED. THE PROCEDURE CONSISTED OF RELINING THE EXISTING COMPONENTS AT THE DEVICE OVERLAP WITH A PLC141000. ANGIOGRAPHY WAS PERFORMED FOLLOWING THE PROCEDURE AND CONFIRMED THAT THERE WAS NO REMAINING E

  Patient problems: Aneurysm

  MAUDE report 13841311 ↗
• InjuryMar 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2022, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY WHEREIN THE PHYSICIAN IDENTIFIED A TYPE 1B ENDOLEAK WAS PRESENT AND DECIDED TO TREAT IT. THE PHYSICIAN DECIDED TO EXTEND THE ORIGINAL DEVICE IN THE RIGHT COMMON ILIAC ARTERY (RCIA) AS IT HAD MIGRATED APPROXIMATE 4CM PROXIMALLY DUE TO DISEASE PROGRESSION (DILATION OF THE RCIA) DISTAL TO THE ORIGINAL DEVICE. TWO ADDITIONAL CONTRALATERAL LEG COMPONENTS WERE IMPLANTED TO SEAL THE RCIA. IN ADDITION, THE PHYSICIAN ALSO EXTENDED THE ORIGINAL GRAFT ON THE LEFT SIDE WITH A CONTRALATERAL LEG COMPONENT TO ENSURE LONG-TERM SEAL ALTHOUGH NO TYPE 1B ENDOLEAK WAS IDENTIFIED ON THE LEFT SIDE. THE ENDOLEAK RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE WELL. PATIENT IS REPORTED TO BE DOING FINE.

  Patient problems: Aneurysm

  MAUDE report 13742228 ↗
• InjuryFeb 15, 2022Partial Blockage; Partial Blockage

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 5.3CM X 4.9CM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND THE INFERIOR MESENTERIC ARTERY WAS EMBOLIZED WITH PENUMBRA RUBY COILS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING WHICH DETERMINED A KINK AND COMPRESSION OF THE CONTRALATERAL LEG COMPONENT IN THE RIGHT ILIAC ARTERY. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE IMPLANTED ON BOTH SIDES. ATLAS KISSING BALLOONS WERE USED TO POST DILATE BOTH SIDES TO 14MM, INTRAVASCULAR ULTRASOUND (IVUS) PERFORMED AT THIS TIME LOOKED GREAT. IT WAS NOTED THAT THE AORTA AT THE LEVEL OF THE BIFURCATION WAS APPX 11MM AND NEAR CIRCUMFERENTIALLY CALCIFIED. THE PATIENT WAS NOT SYMPTOMATIC DENYING ANY CLAUDICATION SYMPTOMS OR ANY LEG PROBLEMS.

  Patient problems: Aneurysm

  MAUDE report 13536161 ↗
• InjuryJan 19, 2022Malposition of Device; Malposition of Device

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND AN ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE GORE FIELD SALES ASSOCIATE WAS PRESENT FOR THE CASE AT SOUTHEASTERN MEDICAL CENTER. IT WAS NOTED THAT VISUALIZATION OF THE GORE DEVICE WAS EXTREMELY DIFFICULT DURING THE PROCEDURE AS THERE WAS A PREVIOUSLY PLACED ENDOLOGIX DEVICE WITH AN ADDITIONAL LAYER OF ENDOLOGIX CUFF. THE ENDOLOGIX DEVICES WERE REPORTEDLY PLACED ON AN UNKNOWN DATE. IT WAS REPORTED THAT, DUE TO THE POOR VISUALIZATION, THERE WAS NO EVIDENCE OF ANY UNINTENTIONAL DEVICE PLACEMENT DURING THE INDEX PROCEDURE. ON AN UNKNOWN DATE THE PATIENT WAS SEEN AT DUKE UNIVERSITY HOSPITAL. AN AXILLARY TO FEMORAL BYPASS WAS PERFORMED AND THE PREVIOUS GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT WAS OCCLUDED USING OCCLUDER PLUGS. THE GORE REPRESENTATIVE BECAME AWARE OF THE REINTERVENTION ON (B)(6) 2021 AND REPORTED THAT, IN REVIEWING IMAGING, IT WAS APPARENT THAT THE GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT HAD BEEN DEPLOYED OUTSIDE OF THE CONTRALATERAL LEG GATE OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE UNINTENTIONAL DEVICE PLACEMENT WAS ATTRIBUTED TO THE

  Patient problems: Insufficient Information

  MAUDE report 13293566 ↗
• InjurySep 8, 2020Break; Break

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ISOLATED RIGHT COMMON ILIAC ARTERY (RCIA) ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND COILING OF THE RIGHT HYPOGASTRIC ARTERY. TWO CONTRALATERAL LEG COMPONENTS WERE IMPLANTED IN THE RCIA. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY REPORTED ISSUES. ON (B)(6) 2020, THE PATIENT PRESENTED TO THE HOSPITAL WITH ACUTE RIGHT FLANK PAIN AND RIGHT URETERAL CALCULUS AND UNDERWENT TREATMENT FOR KIDNEY STONES. DURING INTRAOPERATIVE IMAGING, A FOREIGN BODY WAS VISUALIZED WITHIN THE ABDOMINAL AORTA AND LEFT COMMON ILIAC ARTERY. THE FOREIGN BODY WAS REMOVED USING A ENSNARE CATHETER AND WAS IDENTIFIED TO BE THE LEADING OLIVE AND APPROXIMATELY 17.5 CM OF THE DELIVERY CATHETER INNER LUMEN OF A GORE® CONTRALATERAL LEG COMPONENT INITIALLY IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. DURING THE ORIGINAL IMPLANT THERE HAD BEEN NO ISSUES WITH ADVANCEMENT OR WITHDRAWAL OF ANY OF THE DEVICES. IT WAS REPORTED THAT DURING PREPARATION OF THIS DEVICE BY THE TECH, MUCH DIFFICULTY WAS ENCOUNTERED DURING REMOVAL OF THE DEVICE PACKAGING MANDREL. THE TECH HAD TO PULL VERY FORCEFULLY TO GET IT OUT AND MAY HAVE COMP

  Patient problems: Aneurysm

  MAUDE report 10502469 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis
• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)